The huge late-stage study that is seeking to determine once and for all if Merck's combo cholesterol drug Vytorin actually safeguards lives and is safe will run its full course now that an independent safety board has signed off following a review of the data. And the move inspired at least one prominent analyst to suggest that the green light indicates that things are looking up for IMPROVE-IT, one of Merck's highest profile clinical studies.
In a statement Merck ($MRK) said that the big Vytorin trial, with more than 18,000 patients enrolled, will now run until September 2014, when it is expected to provide conclusive evidence of whether the combination is better that Zocor alone in preventing heart attacks and related deaths.
The safety and efficacy of Vytorin--a combination of Zetia and simvastatin (generic Zocor) which earned $1.75 billion last year--has been in question for years, since a failed Phase III study that was badly delayed while Merck made an attempt to change the primary endpoint--a measure of atherosclerosis. Just days ago Merck agreed to fork over $688 million to settle a pair of securities fraud lawsuits that were brought after the 2008 results were left mired in controversy.
ISI Group analyst Mark Schoenebaum concluded that the go-ahead decision speaks volumes about the drug's apparent safety. The green light "suggests no safety issues," wrote Schoenebaum. "If Zetia/Vytorin were unsafe, would YOU be comfortable waiting another 18 months to look at the data?" And he added that now even the blow of an ultimately negative outcome would be softened by an extension of the franchise to within two year's of Zetia's loss of patent protection at the end of 2016.
That's what Wall Street likes to hear. Merck's shares jumped 4.5% this morning, with some investors breathing a great sigh of relief that the study hadn't been ended as a failure, a threat that has been hanging over Merck for months.
Reuters, though, also notes that some analysts were hopeful that the investigators would find enough positive data to close the trial in triumph. But that didn't happen either.
The whole notion about the LDL heart strategy has come under increasing fire this year, particularly after new data highlighted safety and efficacy problems associated with niacin, which balances good and bad cholesterol. Big Pharma has tapped this field for a number of blockbusters, but without clear evidence that lowering LDL delivers solid health benefits in reducing the risk of deaths and heart attacks, some companies may be forced to reexamine their therapies.
The continuation of the Merck study comes at a time of change for the pharma giant. With one of the weakest late-stage pipelines in the industry, Merck recently tapped Amgen vet Roger Perlmutter to run R&D, where he's expected to bring a fresh eye to a troubled set of assets.
- here's the release
- read the Reuters report